CDISC的SDTMIG，3.2版翻译和学习1---第一章 介绍

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1 Introduction【重点1.4节】

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1.1 Purpose目的

This document comprises the CDISC Version 3.2 (V3.2) Study Data
Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG), which has been prepared by the Submissions Data Standards (SDS) team of the Clinical Data Interchange Standards Consortium (CDISC). Like its predecessors, V3.2 is intended to guide the organization, structure, and format of standard clinical trial tabulation datasets submitted to a regulatory authority such as the US Food and Drug Administration (FDA). V3.2 supersedes all prior versions of the Study Data Tabulation Model Implementation Guide for Human Clinical Trials(SDTMIG).
本IG是由CDISC下属数据递交标准小组（SDS Team）起草，旨在为相关组织，机构，或个人，再向药物监管机构（如FDA）,递交SDTM（Study Data Tabulation
Model）时提供指导。

The SDTMIG should be used in close concert with the current version of the CDISC Study Data Tabulation Model(SDTM, available at http://www.cdisc.org/sdtm) that describes the general conceptual model for representing clinical study data that is submitted to regulatory authorities
and should be read prior to reading the SDTMIG. V3.2 provides specific domain models, assumptions, business rules, and examples for preparing standard tabulation datasets that are based on the SDTM.
**本IG与相应CDISC的SDTM v1.4, https://www.cdisc.org/standards/foundational/sdtm 配套使用。该模型(SDTM)描述了递交给药物监管机构的临床数据的一般概念模型，应当在阅读本IG之前加以阅读。**本IG提供了具体的域模型，前提假设，使用规则和应用SDTM标准的相关示例。

Tabulation datasets, which are electronic listings of individual observations for a subject that comprise the essential data reported from a clinical trial, are one of four types of data
currently submitted to the FDA along with patient profiles, listings, and analysis files. By submitting tabulations that conform to the standard structure, sponsors may benefit by no longer having to submit separate patient profiles or listings with a product marketing application. SDTM datasets are not intended to fully meet the needs supported by analysis datasets, which will continue to be submitted separately in addition to the tabulations. Since July 2004, the FDA has referenced use of the SDTM in the Study Data Specifications for the
Electronic Common Technical Document, available at
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/.
列表数据集包含了临床试验中采集到的受试者的基本数据，是每位受试者每次观测的电子数据集合。通常与受试者综述 (Patient Profiles)，数据报表(Listings)，及分析结果文件 (Analysis files) 一起构成递交给FDA的四种数据类型。通过递交符合标准结构的列表数据集，申办者在递交产品上市申请时，可能不会再被要求一起递交单独的受试者综述(Patient Profiles)或数据报表(Listings)。由于SDTM的设计并非基于分析的目的，并不能像分析数据一样，完全满足分析需求，因而分析数据集仍需要单独递交。自2004年7月，FDA已经在电子通用技术文档的研究数据规范(Study Data Specifications for the Electronic Common Technical Document) 中要求参照使用SDTM，该规范请参见http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/

The availability of standard submission data will provide many benefits to regulatory reviewers. Reviewers can be trained in the principles of standar